U.S. FDA-MEXICO PRODUCE SAFETY PARTNERSHIP - A DYNAMIC PARTNERSHIP IN ACTION

 
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U.S. FDA-MEXICO PRODUCE SAFETY PARTNERSHIP - A DYNAMIC PARTNERSHIP IN ACTION
U.S. FDA-MEXICO PRODUCE SAFETY PARTNERSHIP
A DYNAMIC PARTNERSHIP IN ACTION

                                       June 2018
U.S. FDA-MEXICO PRODUCE SAFETY PARTNERSHIP - A DYNAMIC PARTNERSHIP IN ACTION
Table of Contents

1   Message from the Produce Safety Partnership Leadership
2   Safe Produce: A Cross-border Commitment
    2   The Partnership
    4   Food Safety Modernization in the U.S. and Mexico
5   Impact: Coordinating and Leveraging Produce Safety
    Systems to Support Public Health
8   Partnership Activities
9   What’s Ahead for the PSP?
10 Contact Information for the Produce Safety Partnership
11 Appendix A: PSP Governance Structure
12 Appendix B: PSP Work Groups
U.S. FDA-MEXICO PRODUCE SAFETY PARTNERSHIP - A DYNAMIC PARTNERSHIP IN ACTION
Message from the Produce Safety
Partnership Leadership

We are pleased to present the U.S. FDA-Mexico Produce Safety Partnership: A Dynamic
Partnership in Action progress report.

The Produce Safety Partnership (PSP) is a groundbreaking collaboration to address
the evolving nature of the production and distribution practices facing our respective
countries. This report highlights how Mexico and the U.S. are working together to
ensure the safety of fresh and minimally processed produce.

Recognizing the importance of safe produce to public health and the economy,
Mexico has established a framework for Good Agricultural Practices (GAP). This
framework is based on preventive standards, verification, and certification
programs for fresh produce and covers the full supply chain from growing through
distribution. Mexico has charged its Federal Departments of Agriculture – National
Service for Agroalimentary Public Health, Safety, and Quality (SENASICA) – and
Health – Federal Commission for the Protection from Sanitary Risks (COFEPRIS) –
to work collaboratively to implement its GAP framework and, thus, foster enhanced
produce safety.

The U.S. is also strengthening regulatory approaches to food safety. The FDA
Food Safety Modernization Act (FSMA) of 2011 empowers the U.S. Food and
Drug Administration (U.S. FDA) to better protect public health by implementing
requirements that help to ensure the safety and security of the food supply. FSMA
embraces preventive controls and strong verification processes as the foundation
of a modern food safety system.

We have been working collaboratively on institutionalizing approaches that reinforce
preventive practices and rapid response to potential outbreaks. As explained in this
report, we have worked together to contain potentially serious outbreaks related to
produce and lessen consumer exposure to foodborne disease.

As we move forward, this partnership allows us more flexibility and opportunity to
learn about each other’s food safety systems and leverage new information to find
innovative methods to ensure the safety of produce. We recognize the importance
of establishing strong relationships and mutual support among all stakeholders,
including industry, government, academia, and consumers working together to
ensure food safety.

Dr. Enrique Sánchez Cruz        Stephen Ostroff, M.D.        Lic. Julio Sánchez y Tépoz
     Director in Chief         Deputy Commissioner of          Federal Commissioner
        SENASICA             Foods and Veterinary Medicine            COFEPRIS
                                       U.S. FDA

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U.S. FDA-MEXICO PRODUCE SAFETY PARTNERSHIP - A DYNAMIC PARTNERSHIP IN ACTION
Safe Produce: A Cross-border Commitment

    The PSP is a bilateral partnership that                     grapes, onions, strawberries, potatoes,
    focuses on ensuring the safety of produce                   and peaches to Mexico.
    traded across our respective borders.
    Trade in produce between the U.S. and                       In 2017, Mexico exported over $11 billion
    Mexico is vast. Mexico is a major exporter                  worth of fresh produce to the U.S, and
    of food products to the U.S., providing                     the U.S. exported over $660 million worth
    U.S. consumers with fresh produce                           to Mexico. Figures 1 and 2 identify each
    year-round. Mexico supplies a significant                   country’s top ten fresh produce exports
    percent of the tomatoes, avocados,                          in 2017, by value, and illustrate the
    chilies, berries, cucumbers, lemons, and                    variety of fresh fruits and vegetables that
    limes enjoyed in the U.S. The U.S. exports                  cross our borders.
    a significant amount of apples, pears,

    Figure 1: Mexico Exports of Fresh                           Figure 2: U.S. Exports of Fresh
    Produce to U.S. (by value), 2017                            Produce to Mexico (by value), 2017

                                          Avocados                        1% 6%                          Apples
                           18%                                           1%                              Grapes
                                          Tomatoes                    4% 2%
                                          Raspberries &                                                  Pears
       31%                                                        6%
                                          Blackberries                                                   Onions &
                                          Peppers                                                        Shallots
                                                                 6%                        42%           Strawberries
                                          Strawberries
                                  14%     Grapes                                                         Potatoes
                                          Cucumbers              7%                                      Peaches
     3%                                   Lemons &                                                       Melons &
      3%                         8%       Limes                                                          Papayas
        3%                                Asparagus                    11%                               Kiwifruit
             4%           7%              Squash                                                         Oranges
                  4% 5%                                                           14%
                                          All Others                                                     All Others

    Interactive Tariff and Trade DataWeb. (2018, March 23). Retrieved from https://dataweb.usitc.gov/,
    U.S. Department of Commerce, U.S. International Trade Commission.

    The Partnership

    Foodborne illness outbreaks associated
    with contaminated produce over the                          “Produce is an essential component
    last decade have caused a widespread                        of a healthy diet, so assuring the
    recognition that we need a new, modern                      safety of fruits and vegetables
    food safety system that focuses on                          is a key component of helping
    preventing food safety problems, as well                    consumers achieve healthy diets.”
    as reacting to them. Due to the strong
    commitment that Mexico and the U.S.                         Susan Mayne, Ph.D.
    share to assure the safety of produce,                      Director, Center for Food Safety
    U.S. FDA, COFEPRIS, and SENASICA                            and Applied Nutrition, U.S. FDA
    signed the PSP Statement of Intent on
    July 24, 2014.

2   U.S. FDA-MEXICO PRODUCE SAFETY PARTNERSHIP A DYNAMIC PARTNERSHIP IN ACTION
U.S. FDA-MEXICO PRODUCE SAFETY PARTNERSHIP - A DYNAMIC PARTNERSHIP IN ACTION
The overall goal of the PSP is to
work in collaboration to implement                      “We’ve been delighted to share
preventive practices and verification                   our extensive outreach and
measures that will support high rates                   education materials on worker
of compliance with produce safety                       health and hygiene with our
standards, guidelines and best practices                colleagues from the U.S. FDA.
and therefore reduce risk of illness or                 The PSP has provided a framework
death associated with the consumption of                for sharing creative ideas.”
fresh and minimally processed produce.
The emphasis of the partnership is                      Silvia Rojas
to have a governance structure that                     Director of Agri-Food Safety
focuses on joint activities to facilitate an            Organic Operation and Pesticides
understanding of each other’s produce                   for Agricultural Use, SENASICA
industry oversight systems, coordinated
risk communication, and data sharing for
fresh and minimally processed produce.

Table 1: Missions of the PSP Organizations: COFEPRIS, SENASICA, and U.S. FDA

 COFEPRIS     COFEPRIS is responsible for protecting the population from health risks caused by
              the use or consumption of goods and services, health products, and the exposure
              to environmental or occupational factors.

              COFEPRIS is also responsible for protecting the population from health risks that
              result from the occurrence of sanitary emergencies and the provision of health
              services, through regulation, control, and prevention of sanitary risks.

 SENASICA     SENASICA’s mission is to regulate, manage, and promote the activities of health,
              food safety, and food quality by reducing the risks inherent in agriculture, livestock,
              aquaculture, and fisheries in benefit of producers, consumers, and industry.

              SENASICA is responsible for protecting plants and animals from pests and
              illnesses of economic and quarantine importance. In addition, SENASICA regulates
              and promotes the execution and certification of the voluntary System for Risk
              Reduction from Contamination of fresh fruits and vegetables, for facilitating the
              local and international trade.

 U.S. FDA     The U.S. FDA protects the public health by assuring the safety, effectiveness,
              quality, and security of human and veterinary drugs, vaccines and other biological
              products, and medical devices. The agency also is responsible for the safety and
              security of our nation’s food supply, cosmetics, dietary supplements, and products
              that emit radiation. The U.S. FDA also regulates tobacco products to protect public
              health and reduce use by minors.

              The U.S. FDA’s Center for Food Safety and Applied Nutrition (CFSAN), in
              conjunction with the Agency’s field staff in the Office of Regulatory Affairs, is
              responsible for promoting and protecting the public’s health by ensuring that
              the nation’s food supply is safe, sanitary, wholesome, and honestly labeled,
              and that cosmetic products are safe and properly labeled.

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U.S. FDA-MEXICO PRODUCE SAFETY PARTNERSHIP - A DYNAMIC PARTNERSHIP IN ACTION
Food Safety Modernization in the U.S. and Mexico

    The U.S. and Mexico food safety systems
    are continuously evolving to better               “U.S. FDA’s collaboration
    protect public health by helping to ensure        with Mexico is a key in the
    the safety and security of food supply.           implementation of FSMA and
    The collaboration of the PSP, although            our office in Mexico City has
    not mandated by any legislation, builds           been a linchpin for FSMA
    upon the cross-border commitment to               and PSP implementation.”
    produce safety that the US and Mexico
    share.                                            Mary Lou Valdez
                                                      Associate Commissioner
    For example, FSMA aims to ensure                  for International Programs
    the U.S. food supply is safe by shifting          Office of Global Regulatory
    the focus from response to preventing             Operations and Policy, U.S. FDA
    contamination and foodborne illness.
    In enacting FSMA, the U.S. Congress
    recognized the need to focus on food
    safety at a global scale to address the        Mexico has established a set of laws,
    wide range of commodities the U.S.             regulations, and programs, such as the
    imports from more than 200 countries           voluntary System for Risk Reduction from
    and territories and to assure food is          Contamination (SRRC), to reduce the risk
    safe regardless of its source. It also         of physical, chemical, and microbiological
    recognized that the U.S. FDA cannot            contamination in the primary production
    succeed on its own, but must work              of fruits and vegetables.
    collaboratively with a wide range of
    food system partners – both public and         Mexico has also developed strategies
    private all over the world – to achieve        to strengthen its National Food Control
    established food safety goals.                 System through the enforcement of
                                                   provisions for Good Manufacturing
    In November 2015 FDA issued the FSMA           Practices, which are mandatory for all
    Produce Safety Rule, which establishes         fruit and vegetable growers and packing
    science-based minimum standards for            houses, as applicable. Mexico is also
    the safe growing, harvesting, packing,         moving toward higher standards through
    and holding of fruits and vegetables that      the promotion of Hazard Analysis and
    are domestically produced or imported          Critical Control Point-based certification
    for consumption in the U.S.                    systems.

       “COFEPRIS, as the sanitary authority responsible for the sanitary control and
       surveillance of food, has the scheme for certification of good manufacturing
       practices in food processing establishments, which has allowed more than 200
       certified companies to export safe products, generating confidence for authorities
       and consumers in the countries of destination.”

       Alvaro Pérez Vega
       Commissioner of Sanitary Operation and Enforcement, COFEPRIS

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Impact: Coordinating and Leveraging Produce
Safety Systems to Support Public Health

The PSP is using communications and
enforcement tools to enhance knowledge                 “The examples in this report
transfer and establish common                          demonstrate the significant
processes and procedures between                       progress that can be achieved
the U.S. and Mexico. This collaboration                when public health authorities work
is helping to reduce the impact of                     together to implement preventive
foodborne illnesses by reinforcing                     practices and verification measures
preventive practices before an outbreak                to support high rates of compliance.
occurs and allowing both countries to                  Consumers on both sides of the
respond more rapidly in the event of a                 border are better protected with
potential or actual outbreak.                          access to safe fresh produce.”

The following are examples of how                      Erik Mettler
Mexico and the U.S. have coordinated and               Assistant Commissioner for
leveraged information to make progress                 Partnerships and Policy Office
towards PSP goals.                                     of Regulatory Affairs, U.S. FDA

 Decline Reported in Cyclospora Outbreaks in 2016

 The number of U.S. domestically acquired Cyclospora infections reported in 2016 declined
 when compared to the three previous years. A variety of activities were conducted by the
 U.S. FDA and Mexican food safety authorities in response to epidemiologic and traceback
 information linking Cyclospora cayetanensis (C. cayetanensis) foodborne illnesses to fresh
 cilantro grown in Puebla, Mexico.

 From 2013 to 2015, the U.S. FDA and Mexican food safety authorities SENASICA and COFEPRIS
 performed inspections and environmental assessments at multiple farms and packing houses
 in the state of Puebla, Mexico, where they found conditions and practices that could cause the
 contamination of cilantro. U.S. FDA consulted with Mexican food safety authorities in 2015 to
 implement an annual import alert (Import Alert #24-23) for fresh cilantro from Puebla during the
 growing season of April 1 through August 31. This import alert allows border officials to detain
 and refuse admission of cilantro grown in Puebla into the U.S. without physical examination.

 Only cilantro producers in the state of Puebla who comply with 11 minimum requirements on
 good agricultural and food safety practices as part of Mexico’s SRRC are placed on a “Green List”
 and not detained under the import alert. The PSP facilitated the regulatory coordination between
 the U.S. and Mexico in 2015 prior to the implementation of the import alert. It was agreed that
 the U.S. FDA would review SENASICA and COFEPRIS certification packages for a farm (supplier)
 and for the corresponding packing house being supplied by a SENASICA certified farm prior to a
 firm being added to the Green List.

 The first full season that U.S. FDA’s import alert for fresh cilantro from Puebla, Mexico was in
 effect was 2016. As of September 16, 2016, U.S. Centers for Disease Control and Prevention
 (CDC) reported at least 134 laboratory-confirmed cases of cyclosporiasis in persons who became
 infected in the U.S. and reported illness onset on or after May 1, 2016. This was a 58-percent

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(58%) reduction compared to the same period in 2015, which had 319 confirmed cases. It is worth
     noting that the CDC reported an increase in the number of laboratory-confirmed cyclosporiasis
     cases in 2017, but additional data are needed to determine if the increase is due to more
     frequent testing or to an actual increase in infections.

     Prior to the existence of the PSP, this level of joint action was not routine between the countries.
     This experience also led FDA to implement a testing program for cilantro from Puebla, Mexico
     and to conduct industry outreach on C. cayetanensis control and prevention in partnership with
     the CDC.

       “In just a few short years, we have seen the U.S. FDA-Mexico Produce Safety
       Partnership grow from concept to reality. We are seeing cooperation on a variety of
       fronts, from lab procedures to data collection and sharing. As the United States and
       Mexico have become such strong partners in the food chain, this evolution has been
       welcomed and we think in the coming years it will yield even greater benefits to
       consumers, regulators, and industry alike.”

       Lance Jungmeyer
       President, Fresh Produce Association of the Americas

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Information Shared During an Outbreak of U.S. Kiwi and Apples

 During an outbreak in 2015 for U.S. kiwi and apples, the exchange of information under the
 PSP led to activities that further prevented contaminated product from entering Mexico.

 In August 2015, COFEPRIS informed the U.S. FDA Latin America Office (LAO) in Mexico City
 about U.S. fresh produce sampled by SENASICA found to be positive for Listeria monocytogenes.
 A week later, COFEPRIS shared the analytical worksheets of the laboratory findings with LAO.

 The PSP Laboratory Collaboration work group assisted the U.S. FDA/CFSAN’s Office of
 Regulatory Science and Office of Food Safety in working with the U.S. FDA LAO in Mexico City
 to submit a request for the L. monocytogenes isolates to be shipped from SENASICA’s laboratory
 to U.S. FDA. The isolates were from U.S. kiwi and apple samples collected at the border of
 Mexico. CFSAN performed Pulse Field Gel Electrophoresis and Whole Genome Sequence
 analyses on the isolates from SENASICA. Once performed, the U.S. FDA LAO shared the results
 with PSP Mexican food safety authorities COFEPRIS and SENASICA.

 Prior to the existence of the PSP, the ability to share information fluidly between the U.S.
 and Mexican food safety authorities was not easily done. Due to joint action between the
 organizations, the ability to conduct an exercise for a Listeria isolate transfer allowed the food
 safety authorities to exchange information and enhance collaboration on laboratory activities,
 to improve detection and understanding of contamination. This exercise is establishing a
 two-way protocol for the exchange of strains between Mexico and the U.S.

                                                      “SENASICA operates the Good
                                                      Agricultural Practices program
                                                      called the SRRC, which is
                                                      implemented in farms and
                                                      packinghouses of fresh fruits and
                                                      vegetables. In addition, the scheme
                                                      ensures that products certified
                                                      under the Mexican government
                                                      program comply with national
                                                      and international regulations in
                                                      food safety by reducing physical,
                                                      chemical, and microbiological
                                                      contamination. At present,
                                                      more than 10,000 companies and
                                                      producers are certified in our
                                                      scheme, producing more than
                                                      80 species of fresh fruits and
                                                      vegetables in optimal food safety
                                                      conditions and ready to eat.”

                                                      Hugo Fragoso Sánchez
                                                      General Director for Food Safety,
                                                      Aquaculture, and Fisheries,
                                                      SENASICA

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Collaborating to Increase Prevention

     Collaboration using mechanisms developed under the PSP led to activities to prevent further
     contamination in papaya from Mexico.

     In the fall of 2017, the U.S. FDA and Mexican food safety authorities, SENASICA and COFEPRIS,
     used mechanisms established by the PSP in their response to four outbreaks of human
     infections with Salmonella epidemiologically and analytically linked to papaya originating from
     Mexico. U.S. FDA used the Binational Outbreak Notification Protocol established under the PSP
     to notify SENASICA and COFEPRIS of the outbreaks.

     The Mexican agencies conducted inspections and sampling at various farms and packing
     houses in several Mexican states, with U.S. FDA joining one. They shared results with U.S.
     FDA showing several samples matching outbreak strains. Additionally, the Mexican authorities
     observed conditions and practices that could lead to the contamination of papaya. U.S. FDA
     used these findings, along with its outbreak investigation, to place four farms on Import Alert
     99-35, “Detention Without Physical Examination of Fresh Produce That Appears to Have Been
     Prepared, Packed or Held Under Insanitary Conditions” and SENASICA likewise implemented
     a regulatory response.

     Additionally, U.S. FDA isolated Salmonella in papaya, not matching the outbreak strains, during
     examination of several entries and placed several Mexican firms on an existing country-
     wide import alert for papaya, Import Alert 21-17, “Countrywide Detention Without Physical
     Examination of Papaya From Mexico.” This alert was put in place in 2011 in response to multiple
     contamination events including a large outbreak of salmonellosis in which papaya from Mexico
     was implicated as the vehicle. While outbreaks from consumption of papaya were not identified
     in 2012-2016, the 2017 outbreaks demonstrate that there are continued challenges in preventing
     Salmonella contamination of papaya.

     To further prevention efforts and in response to the papaya outbreaks, SENASICA implemented
     a program in October 2017, to strengthen the safety of papaya by incorporating minimum
     food safety requirements through adherence to the SRRC when issuing the International
     Phytosanitary Certificate, (Certificado Fitosanitario Internacional, CFI), to companies exporting
     papaya to the U.S. SENASICA implemented its program to minimize the potential for
     contamination of papayas with Salmonella in the Mexican papaya industry. Beginning in
     January 2018, papaya produced by, or exported to the U.S. from, large farms must meet the
     science-based minimum standards of FDA’s Produce Safety Rule.

    Partnership Activities

    Initially the PSP focused on learning about our respective organizations and deepening
    the understanding of how our respective food safety systems functioned. Mexico
    and the U.S. have cooperated on joint inspections and responses to produce-related
    outbreaks, such as joint traceback investigations and environmental assessments,
    in addition to enhancing laboratory capacity. Mexican officials from both COFEPRIS
    and SENASICA routinely accompany U.S. FDA during surveillance inspections at
    Mexican food firms, including produce firms. Likewise, U.S. FDA accompanies
    COFEPRIS and SENASICA during inspections of U.S. produce farms and facilities
    that export to Mexico.

    In addition, the PSP conducted the following activities:

8   U.S. FDA-MEXICO PRODUCE SAFETY PARTNERSHIP A DYNAMIC PARTNERSHIP IN ACTION
•   Established a written protocol through a confidentiality agreement to exchange
    information within the PSP
•   Exchanged information on outbreak response, which contributed to the
    development of a Binational Outbreak Communication Protocol to establish the
    basis of communication and information exchange between Mexico and the U.S.,
    to respond to outbreaks caused by the consumption of contaminated fresh and
    minimally processed produce
•   Established an information-sharing platform through FoodSHIELD - a web-based
    system at the University of Minnesota for communication, coordination, education,
    and training among the U.S.’s food and agriculture sectors - to act as a repository
    for uploading and reviewing information
•   Shared information on laboratory validation methods used by all three agencies
•   Shared microbial strain isolates and information on laboratory methodologies to
    isolate and identify the main foodborne pathogens in produce
•   Observed respective inspectional approaches and shared information on training
    methods for auditors for SENASICA and inspectors for COFEPRIS and U.S. FDA
•   Developed a catalogue of web accessible educational materials and an internal
    glossary for operational and regulatory food safety technical terms for consistency
    purposes
•   Shared information on capacity building and education and outreach materials
•   Assisted Mexico with PulseNet certification to implement Pulsed-field Gel
    Electrophoresis for Salmonella
•   Held periodic conference calls and in-person meetings in Mexico (September 2014
    and September 2016) and the U.S. (April 2017)

What’s Ahead for the PSP?

The PSP consists of more than 50 dedicated individuals. Appendix B contains
information on the PSP workgroups. Our collective body of work represents an
opportunity for further engagement to continue improving the safety of fresh
and minimally processed produce.

                                             Over the next five years, the PSP will
    “There has been extraordinary            explore the following:
    cooperation on laboratory methods
    and procedures over the last             •   Increasing engagement with key
    few years. Mexico and the U.S.               partners in industry, academia,
    have taken giant steps forward in            and government to further advance
    bringing our laboratories closer.”           opportunities for the PSP
                                             •   Exchanging of information and
    Mario Alanís Garza                           knowledge, regarding Whole Genome
    General Director of International            Sequencing methods, practices, and
    Affairs, COFEPRIS                            collaborative activities

U.S. FDA-MEXICO PRODUCE SAFETY PARTNERSHIP A DYNAMIC PARTNERSHIP IN ACTION                9
•   Identifying common approaches for auditors and inspectors to improve various
         tools and procedures for effective compliance and better execute compliance and
         enforcement activities
     •   Creating a strategy to conduct joint inspections and a joint pilot on micro-sampling
         to improve surveillance, detection, and understanding of contamination and to
         improve decision making for response actions
     •   Continuing to advance the Binational Communications Outbreak Protocol by
         evaluating its effectiveness and including specific time frames to enhance
         its execution
     •   Enhancing FoodSHIELD features for PSP purposes
     •   Incorporating other matters of interest, such as food alerts and recalls

     The PSP will continue to leverage information and embrace opportunities that arise
     to implement preventive practices and verification measures to support high rates
     of compliance with produce safety standards, guidelines, and best practices.

     Contact Information for the
     Produce Safety Partnership

     To contact COFEPRIS, please send an email to the Executive Directorate
     of International Operations at deoi@cofepris.gob.mx.

     To contact SENASICA, please send an email to
     alianzainocuidad.dgiaap@senasica.gob.mx.

     To contact the U.S. FDA, please send an email to the International Affairs Staff
     in CFSAN at IAS-ACTION@fda.hhs.gov.

10   U.S. FDA-MEXICO PRODUCE SAFETY PARTNERSHIP A DYNAMIC PARTNERSHIP IN ACTION
Appendix A
PSP Governance Structure

                                                       Executive Council

 Advisory Team                                       Steering Committee

Project Managers                                          Chairpersons

  Work Group 1          Work Group 2         Work Group 3         Work Group 4        Work Group 5
  Produce Safety        Education and     Training of Auditors     Laboratory          Outbreak
System Information        Outreach           & Inspectors         Collaboration        Response
     Sharing

   USFDA, SENASICA and COFEPRIS
           representation

 Executive           Consists of senior-level individuals who provide guidance to the PSP
 Council             Steering Committee when necessary. The Executive Council provides
                     direction or resolution to the PSP Steering Committee when a consensus
                     cannot be reached.

 PSP Steering        Consists of director-level individuals who meet periodically to provide
 Committee           direction, address issues, review information, and provide final approval
                     for the work of the PSP. This includes reviewing proposals and designating
                     individuals to work on the PSP and its activities. The Steering Committee
                     meets on a quarterly or as-needed basis by phone and face-to-face.

 Chairpersons        Oversee execution of the direction and decisions made by the PSP Steering
                     Committee and Executive Council. They are responsible for disseminating
                     updates and monitoring the progress of the Work Groups. Chairpersons
                     provide regular updates to the PSP Steering Committee or the Work Groups
                     on significant issues that may impact the PSP’s mission or scope. They are
                     also responsible for reviewing information and proposals prior to being
                     delivered to the PSP Steering Committee for approval.

 Work Groups         The collaboration of the PSP is carried out by specific technical work groups
                     devoted to key areas relating to produce safety. Five work groups conduct
                     activities to develop knowledge of and mutual confidence in the approaches
                     used by the U.S. and Mexican produce safety control systems.

U.S. FDA-MEXICO PRODUCE SAFETY PARTNERSHIP A DYNAMIC PARTNERSHIP IN ACTION                           11
Appendix B
     PSP Work Groups

      Work Group         Charge                    Expected Outcomes        Voice of the
                                                                            Work Groups

      1. Information     Focused on how best to    •   Better prevention    “Working together
         Sharing         exchange information          of produce safety    to understand each
                         between organizations         problems in the      other’s regulatory
                         about produce safety          produce supply       activities and
                         systems to increase           chain                challenges can
                         understanding and         •   Increased            only strengthen our
                         knowledge, recognize          compliance           relationship.”
                         and better target             with regulatory
                         high-risk situations          standards            “Sharing information
                         involving produce,        •   Increased mutual     can help identify needs
                         and better execute            confidence in the    for more targeted
                         compliance and                way Mexico and       approaches and
                         enforcement activities.       the U.S. approach    increased regulatory
                                                       produce safety       cooperation.”

      2. Education and   Dedicated to the          •   Increased access     “A common
         Outreach        development of                to and knowledge     understanding of the
                         effective, culturally         of information       terminology used by
                         specific education            related to           each agency has been
                         and outreach materials        improved practices   reinforced.”
                         that support industry         for industry
                         compliance with           •   Better prevention    “Through PSP, we can
                         standards for the             of produce safety    build upon our alliance
                         safety of fresh and           problems in the      to decrease risks and
                         minimally processed           produce supply       ensure a safer food
                         produce.                      chain                supply.”

      3. Training of     Focused on sharing        •   Improved tools       “PSP gives us an
         Auditors and    information to identify       and procedures       opportunity to learn
         Inspectors      common approaches             for effective        more about each
                         for training auditors         compliance           other’s policy-making
                         and inspectors who        •   Better execution     activities for audits
                         will verify compliance        of compliance        and inspections.”
                         with standards for the        and enforcement
                         safety of fresh and           activities
                         minimally processed
                         produce.

12   U.S. FDA-MEXICO PRODUCE SAFETY PARTNERSHIP A DYNAMIC PARTNERSHIP IN ACTION
Work Group         Charge                     Expected Outcomes        Voice of the
                                                                        Work Groups

 4. Laboratory      Focused on enhancing       •   Improved             “We have discovered
    Collaboration   the collaboration of           surveillance,        that we share a
                    ongoing laboratory             detection, and       common theme in the
                    activities.                    understanding of     importance of science-
                                                   contamination        based preventive
                                               •   Improved decision    standards.”
                                                   making for
                                                   response actions     “Through PSP, we
                                               •   More effective and   have an opportunity
                                                   efficient response   to share information
                                                   efforts for known    on scientific methods
                                                   hazards              such as Whole
                                                                        Genome Sequencing
                                                                        and participate in
                                                                        joint laboratory
                                                                        projects that augment
                                                                        our cross-border
                                                                        commitment to ensure
                                                                        the safety of produce.”

 5. Outbreak        Dedicated to enhancing     •   Improved             “PSP is an example
    Response        collaboration during           surveillance         of a true partnership
                    outbreak response and          and detection of     between countries and
                    traceback activities, as       contamination        has opened doors for
                    well as epidemiology       •   Improved             more communications,
                    and product tracing for        epidemiology and     especially during
                    Mexico and the U.S.            product tracing      critical times in food
                                                   for Mexico and       safety.”
                                                   the U.S.
                                               •   Improved decision    “Our work together
                                                   making for           on Whole Genome
                                                   response actions     Sequencing is an
                                                   and more efficient   example of how we
                                                   and effective        have to work and
                                                   responses to         communicate together
                                                   known hazards        to ensure there is
                                                                        understanding across
                                                                        the board.”

U.S. FDA-MEXICO PRODUCE SAFETY PARTNERSHIP A DYNAMIC PARTNERSHIP IN ACTION                        13
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